Lead quality assurance activities for Class III combination medical devices and blood components, supporting design control, SDLC/IEC 62304 compliance, risk management, verification/validation, audits, supplier quality, CAPA, traceability, and product release. Maintain quality metrics and documentation, support cybersecurity and software lifecycle activities, and drive continuous manufacturing quality improvements.

The QA Automation Engineer will focus on automation using Selenium, integrate APIs, and work with SQL and No-SQL databases.